This Funding Opportunity Announcement (FOA) solicits
applications from institutions/organizations to participate in NCI's
Community Oncology Research Program (NCORP) as NCORP Community Sites. The
goal of NCORP is to build upon the scope and activities of NCI's previously
supported community networks, the Community Clinical Oncology Program (CCOP)
which includes CCOP community sites (CCOPs), Minority-Based CCOP sites
(MB-CCOPs), and CCOP Research Bases, and NCI's Community Cancer Centers'
Program (NCCCP) by establishing a single community-based research program.
NCORP will be an integrated national network to: 1) design and conduct cancer
prevention, control, and screening clinical trials; 2) design and conduct cancer
care delivery research; 3) enhance patient and provider access to treatment
and imaging clinical trials conducted under the reorganized National Clinical
Trials Network (NCTN); and 4) integrate disparity research questions into
clinical trials and cancer care delivery research.

NCORP will consists of three components each with its own
FOA: NCORP Research Bases; NCORP Community Sites (covered by this FOA); and
NCORP Minority/Underserved Community Sites.

The NCORP Community Sites will accrue
patients/participants to NCI-approved cancer clinical trials and cancer care
delivery research designed by NCORP Research Bases and NCTN Groups.

Key
Dates

Posted Date

November 8, 2013

Letter of Intent Due Date(s)

December 8, 2013

Application Due Date(s)

January 8, 2014

AIDS Application Due Date(s)

January 8, 2014

Scientific Merit Review

March-April 2014

Advisory Council Review

May 2014

Earliest Start Date

September 2014

Expiration Date

January 9, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS 398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all
grant programs to electronic submission using the SF424 Research and Related
(R&R) format and is currently investigating solutions that will accommodate
NIH’s multi-project programs. See NOT-OD-13-075 and NIH’s Applying Electronically website for more information.

This Funding Opportunity Announcement (FOA) is one of three
FOAs that implement the NCI Community Oncology Research Program (NCORP). The
overall goal of NCORP is to bring cancer clinical trials, as well as cancer
care delivery research, to individuals in their own communities, thereby
generating a broadly applicable evidence base that contributes to improved
patient outcomes and a reduction in cancer disparities.

Note: The NCTN structures are evolving from the current main clinical trials program,
the NCI Clinical
Trials Cooperative Groups. Because not all awards for the NCTN components
may be in place at the time of NCORP application submission, the further text
related to FOA requirements provides dual references, e.g., "Clinical
Trials Cooperative Groups or NCTN Operations Centers".

NCORP will support the following components that will be
individually awarded through the respective FOAs indicated below:

NCORP
Research Base is defined as a research hub for NCORP program.
Research Bases must be located at leading institutions with comprehensive
expertise in cancer clinical trials, such as institutions that are cancer
foundations, healthcare research organizations (including sites of Clinical
Trials Cooperative Groups or NCTN Group Operations Centers), NCI-designated Cancer
Centers, or integrated healthcare systems. These institutions must have an
established organizational structure for the design and conduct of multi-center
cancer prevention, control and screening/post-treatment surveillance clinical
trials and cancer care delivery research. The Research Base provides scientific
and statistical leadership for developing, implementing, and analyzing
multi-institutional cancer prevention, control, and screening/post-treatment
surveillance clinical trials, quality-of-life studies embedded within treatment
and imaging clinical trials and studies on cancer care delivery. The Research
Bases will be responsible for study operations and data management, including
timely protocol development, compliance with Food and Drug Administration (FDA)
and Office of Human Research Protections (OHRP) regulatory and participant
protection requirements, audits, training, quality assurance, and site support.

NCORP
Community Site is defined as a consortium of community hospitals
and/or oncology practices or a community-based integrated healthcare system
that accrues participants to: 1) cancer prevention, control, and screening/post-treatment
surveillance clinical trials designed and conducted by the NCORP Research
Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well
as quality-of-life studies embedded within them; and 3) cancer care delivery
research where “participants” can be defined as patients, practitioners, and/or
healthcare organizations.

NCORP
Minority/Underserved Community Site is defined as a consortium of
community hospitals and/or oncology practices, a public hospital, or academic
medical center that has a patient population comprising at least 30%
racial/ethnic minorities or rural residents and accrues participants to: 1)
cancer prevention, control, and screening/post-treatment surveillance clinical
trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored
cancer treatment and imaging clinical trials, as well as quality-of-life
studies embedded within them; and 3) cancer care delivery research where
“participants” can be defined as patients, practitioners, and/or healthcare
organizations.

This FOA solicits applications specifically for NCORP
Community Site awards. Applicants interested in other NCORP components must use
an appropriate companion FOA.

Background

Although cancer clinical research has traditionally been
conducted at academic medical centers, the bulk of cancer care takes place in
the community setting. Expanding clinical research beyond the academic
environment allows access to a larger and more diverse patient population
treated in a variety of “real-world” healthcare delivery settings, which can
accelerate accrual to clinical trials, allow for feasibility testing of
promising new interventions in variable care environments, and increase the
generalizability and relevance of study findings. Engaging community
oncologists in collaborative research can also facilitate the uptake of
effective, evidence-based practices into routine care.

In recognition of the importance of community-based clinical
research, three decades ago, the NCI launched the Community Clinical Oncology
Program (CCOPs, MB-CCOPs, and CCOP Research Bases) to form a clinical trials
network to expand patient and physician access to cutting-edge cancer treatment
clinical trials outside of traditional academic medical settings, as well as
develop multi-institutional cancer prevention, control and screening clinical
trials. In the years since, the CCOP network has become a key component of the
national cancer clinical trials enterprise, contributing a substantial
proportion of accrual to phase 2 and 3 treatment and imaging clinical trials
with significant representation of minority patients, and implementing a series
of pivotal and influential multi-institutional clinical trials in cancer
prevention, control, and screening as well as health related quality of life
studies. In 2007, the NCI’s Community Cancer Centers Program (NCCCP) was initiated to explore ways in
which community hospitals could enhance access to care, improve the quality of
care, and expand research across the entire cancer continuum with a focus on
diverse racial, ethnic, and underserved populations.

Strong clinical trial programs remain essential to address
the many unmet needs in cancer prevention, control, screening, and treatment.
Yet findings from health services research and the promising role of quality
improvement initiatives underscore the critical, complementary role of care
delivery structures, processes, and organizational policies as determinants of
patient care experiences and outcomes. Systematic studies and improvement of
these factors are important in assuring that all patients, specifically those from
minority/underserved populations, benefit from the best available knowledge
about cancer prevention, control, screening, and treatment.

The importance and influence of cancer care delivery on
patient care have led to the emergence of cancer care delivery research as a
multidisciplinary field of scientific investigation that studies how complex,
multi-level forces including social factors, financing systems, organizational
structures and processes, health technologies, provider and individual behaviors
affect cancer outcomes, access to cancer care, the quality and cost of cancer
care and ultimately the health and well-being of cancer patients and survivors.
Its focus includes individuals, families, organizations, institutions,
providers, communities, populations, and their interactions. As the bulk of
cancer care occurs in a community setting, community-based care organizations
must be a key focus of cancer care delivery research that seeks to understand
and improve patient outcomes based on these factors.

Goal, Scope, and Strategy of the NCORP

NCORP, while maintaining a vigorous program for the design
and conduct of cancer prevention, control, and screening clinical trials and
participation in NCTN treatment and imaging clinical trials, will expand the
scope of activity to include cancer care delivery research. An important
component of NCORP will be research on the diverse and multi-level factors that
affect access to and quality of care in the community and also increase the
focus on minority/underserved populations that are underrepresented in clinical
trials and for which cancer care delivery issues are of great importance.

During the start-up and initial phase of NCORP, the expected
relative balance in the level of effort between clinical trials and cancer care
delivery research will be approximately 90% and 10%, respectively for a given
Research Base and this is reflected in the FOA funding estimates. However,
funding from other sources can be used to augment the cancer care delivery
research efforts.

To address these goals, it is anticipated that NCORP
awardees will focus on the following activities:

Implementing an integrated national network of community
organizations and Research Bases that will: 1) design and conduct cancer
prevention, control, and screening/post-treatment surveillance clinical trials;
2) design and conduct multi-level cancer care delivery research; and 3) enhance
patient and provider access to treatment and imaging clinical trials conducted
under the reorganized NCTN.

Facilitating the participation of minorities and other
underserved populations across all study types and settings.

Increasing the integration of health disparities questions across
all study types and settings.

Integrating the expertise of primary health care providers, other
specialists, and health services and behavioral researchers with oncologists,
especially as they relate to transition in care.

Accelerating the translation of knowledge gained from cancer
clinical trials into clinical practice.

Accelerating the transfer of knowledge from cancer care delivery
research into healthcare systems and organizations.

The current CCOP agenda for clinical trials is expected to
be continued under NCORP as its predominant activity. Specifically, the NCORP
agenda is expected to include the following aspects:

Cancer prevention research aimed at identifying and evaluating
interventions to reduce cancer risk and incidence.

Cancer control research aimed at reducing the incidence and
co-morbidity of cancer and its treatment and enhancing the quality of life of
those affected by cancer.

Cancer screening research aimed at evaluating early diagnosis and
recurrence of cancer.

Secondary endpoints of health-related quality of life or
patient-reported outcomes in NCTN treatment trials.

New areas of special emphasis will include studies
addressing mechanisms of cancer symptoms and treatment-related toxicities,
observational or longitudinal studies to understand the natural history of
cancer symptoms and treatment-related toxicities, molecularly targeted agents
to understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis,
and management of precancerous lesions. Post-treatment surveillance studies
will evaluate the use of optimal screening modalities or tumor markers designed
to detect recurrences of cancers following curative intent. Methods of
diagnosis for cancers will be collected within NCORP trials to facilitate the
collection of data required to evaluate over and under diagnosis of cancers (e.g.,
screening interval breast cancers).

NCORP will also build an infrastructure and research agenda
for cancer care delivery research that includes the following:

Developing the necessary data infrastructure and site training
for the conduct of studies.

Analyzing new or existing data to better understand current
patterns of cancer care in the community setting.

Interventional studies of approaches (single and multi-level
studies) to improve care delivery practices across the cancer continuum (e.g.,
decision-making tools to support genomically-informed diagnostic testing or
therapies); new approaches for team-based care such as multi-modality therapy
planning and delivery, patient navigation or other care processes to evaluate
care transitions and the incorporation of patient reported information into
clinical decision-making).

The NCORP cancer disparities research agenda will integrate
into clinical trials and cancer care delivery research, as appropriate, the
following:

Studies to enhance participation of racial/ethnic and other
underserved populations underrepresented in research.

Evaluation of concepts for clinical trials and cancer care
delivery research for scientific merit by NCI-managed steering committees
composed of leading experts from the extramural community in cancer prevention,
control, screening/post-treatment surveillance, care delivery and disparities,
community oncologists and patient advocates, consistent with national
priorities for cancer prevention, control, and screening/post-treatment
surveillance clinical trials and cancer care delivery research.

Efficient and timely activation, conduct, and completion of
studies, through the effective integration of scientific expertise with
operational management capabilities.

Incorporation of innovative science into clinical trials and
cancer care delivery research through collaboration with institutions and investigators
conducting basic or early phase clinical trial research relevant to cancer
prevention, control and screening as well as those conducting exploratory
research on new care delivery approaches and methodologies.

Program Evaluation: NCORP will be subject
to external evaluation (to be coordinated by NCI Program Staff) near the end of
the project period. Such evaluation is part of NIH efforts to optimize the
efficiency of funded research.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH staff will assist,
guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER
Glossary and the PHS 398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The National Cancer Institute intends to commit an
estimated total of $40.8 million ($35.4 million for cancer clinical trials
and $5.4 million for cancer care delivery research studies) for up to 40
awards in FY 2014. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited, but need to reflect the
actual needs of the proposed project. Because the nature and scope of the
proposed research will vary from application to application, the size of each
award will also vary .

Award Project Period

5 years

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

A Lead Academic Program (LAP) funded by the Division of Cancer
Treatment and Diagnosis (DCTD), NCI.

Department of Veterans Affairs hospitals or military treatment
facilities are not eligible to apply, but may be included in an application as
a member of a consortium led by a qualified applicant, although they may not be
the applicant organization or the major contributor to patient accrual.

Institutions funded as clinical trials cooperative group
affiliate programs are not eligible to apply unless they state in the
application that support through this mechanism will be relinquished if a NCORP
Community Site cooperative agreement is awarded.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the PHS 398 Application Guide to be
eligible to apply for or receive an award. All registrations must be completed
prior to the application being submitted. Registration can take 6 weeks or
more, so applicants should begin the registration process as soon as possible.
The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet Universal
Numbering System (DUNS) - All registrations require that applicants be
issued a DUNS number. After obtaining a DUNS number, applicants can begin both
SAM and eRA Commons registrations. The same DUNS number must be used for all
registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Each applicant organization may submit only one application
in response to this FOA.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally submitted
to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Address to Request
Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the PHS 398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Applicants should provide within the budget
justification an itemization showing for each expense category how the entire
period budget is divided between Clinical Trials expenses and expenses for
Cancer Care Delivery Research.

NOTE: Budget requests may include the following items:
partial support for the PDs/PIs salaries but ONLY for time spent on NCORP organizational/administrative
tasks; salary support for full or part-time research nurses, pathologists, administrative
personnel, data managers, and study assistants; supplies and services directly
related to study activities (e.g., processing and sending material for
pathology review, processing and sending port films for radiation therapy
quality control); handling of investigational drugs related to NCI-approved
protocols; travel to meetings directly related to study activities (e.g.,
research base meetings, NCI-sponsored strategy sessions/workshops, local
travel); and special personnel needed to support the recruitment and retention
of eligible minority participants on clinical trials/studies.

The following items are NOT allowed in the budget
requests: costs of clinical care provided to patients (e.g., for patient care
reimbursement, transportation costs); salary support for clinical support
personnel (e.g., physicist, clinical psychologist, and dosimetrist); and physician
compensation (other than specified above for PD/PIs for their NCORP Community
Site related administrative activities).

Biographical Sketch

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Resources

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

In addition to standard information, provide in this
section documentation of important capabilities and available resources as
indicated for specific functional components of the NCORP Community Site below.
Relevant information may be provided in tabular form as listed below.
Applicants are strongly encouraged to use, as appropriate, table templates
provided at http://prevention.cancer.gov/ncorp.

Table 1 – NCORP Components/Sub-components

Table 2 – NCORP Site Accrual Record

Table 3A – Currently Active NCI Clinical trials

Table 3B – NCI Clinical trials Expected to be
Activated

Table 4 – Current and/or Planned Research Base
Affiliations

Table 5 – NCORP Site Capabilities

Table 6 – Past Experience in Cancer Care Delivery
Research

Table 7 – Audit Summary Report

Table 8 - Number of Newly Diagnosed Cancer Patients
by Site

Facilities: List and provide specific details on the available facilities,
including laboratories, inpatient and outpatient resources, cancer registries,
affiliated providers, delivery systems, etc. Clearly describe space available
for administrative activities and personnel to serve as primary locus for data
management, quality control, and communication. The description of this
administrative space may be included in the Resources Section.

Other
Commitments: Provide factual details documenting other resources
committed to the program by the participating institutions.

Research Plan

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Specific
Aims: Outline the Specific Aims of the proposed Community Site,
indicating how they fit into the overall goals of the NCORP Program and the key
requirements of the FOA.

Research
Strategy: This section must consist of the sub-sections A-E
described below.

Sub-Section
A. Organization and Structure

Organizational
Structure for NCORP Research Activities.
Describe the current and/or planned organizational structure under which the
applicant proposes to conduct clinical trials and cancer care delivery
research. Include an organizational chart.

NCORP Community Sites are expected to function as
consortia of the Community Site awardee institution and several partners.
Depending on the relationship to the proposed Community Site institution,
specific partners are referred to as NCORP
Community Site "components" or "sub-components".

Definition
of Community Site Component: In the context of NCORP Community Site
structure, a "component" refers to a hospital, cancer center,
physician practice, or other institution where patients/participants are
enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials
available to the NCORP Community Site. In addition, one or more of the NCORP Site
components are expected to participate in cancer care delivery research.
Community Site awardee will be regarded as a "primary component".

Definition
of Community Site Sub-Component: In the context of NCORP Community
Site structure, a "sub-component" refers to a practice or
organization that contributes to the overall accrual of a component site but is
located in a separate geographic location(s), is part of the component’s
business entity, and is managed by the component.

If the NCORP Community Site applicants propose more
than one component or sub-component, each must be listed to be considered part
of NCORP. Describe the relationship of component(s)/sub-component(s) to each
other and to the NCORP awardee Community Site, if applicable. Include a diagram
showing the distance between these entities (including administrative office
and shared resources) and location of proposed personnel.

NOTE: Information on the applicant’s component(s)/subcomponent(s) may be
summarized in a table as described in the Resources Section above.

The applicant should identify at least one component
that will participate in cancer care delivery research. Provide rationale to
justify why specific component(s) are selected for this role. The component(s)
should be able to implement on-site cancer care delivery research, provide
organizational data (e.g., financial, service utilization, processes of care)
in support of cancer care delivery research, and mentor other component(s) in
their NCORP awardee network in cancer care delivery research. These
capabilities can all be provided by a single component or by more than one
component. Alternatively, the various capabilities may be distributed over two
or more different components. If the applicant has more than one component
designated to participate in cancer care delivery research, describe the
relationship of component(s) to each other.

Catchment
Area.The applicants must delineate their catchment area. A map of the
service area, designating counties or zip codes from which approximately 80
percent of the patients will be drawn, should be provided. Provide an estimate
of the percentage of oncologists in the service area that will participate in
the NCORP Community Site and a description of patient referral patterns within
the catchment area. A description of other cancer care resources in the
catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are
not part of the application should be included. A description of the study
population in the applicant’s catchment area should be provided with
percentages by gender, race and ethnicity, as well as measures of social
deprivation, such as socioeconomic status, poverty status and insurance status.
Applications should provide information regarding the percentage of patients in
the catchment area for the following age categories: 1-15, 15-39, 40-64, 65+;
and percentage of patients in their cancer registries over the age of 65.

Clinical
Practice Structure and Partnerships. Describe the types and sizes
of the participating components/subcomponent(s) that will be included in the
NCORP Community Site (e.g., outpatient/inpatient practices,
hospitals/clinics/cancer centers), as well as the number of participating
oncologists, primary care and other providers. Describe relationships with
primary care and other providers that will be research collaborators with the
applicant. Relationships with key community partners (e.g., faith-based organizations,
advocacy groups, and community coalitions) and planned strategies to engage the
community partners in increasing clinical trials education and outreach and
facilitating wider community participation by patients and providers in
clinical trials and cancer care delivery research should be described.

Institutional
Commitment.All the consortium components' must be
fully committed to participation in clinical trials, and, as applicable, cancer
care delivery research. This section of Reasearch Strategy should include
strategic statements and overview narrative relevant to the commitments to the
program.

Facilities. Briefly describe the salient features of the facilities and other
resources available (committed) for use by the proposed Community Site. Indicate
the main efforts needed (or already conducted) to integrate these
facilities/resources into one functional system, in particular if they are in
geographically different locations and/or in different institutions. If
appropriate, include a map or a scheme showing all the locations and their
connectivity (by roads, by information technology, etc.). Indicate any systemic
cross-institutional/cross-location enhancments that might be needed and are
planned by the participating institutions. Specify any actions that are needed
to ensure that appropriate space is available for administrative activities and
personnel to serve as primary locus for data management, quality control, and
communication.

Sub-Section
B. Leadership

Outline the leadership structure and the roles of
PD/PI and other senior investigators. [Note that for applications designating
multiple PD(s)/PI(s), a separate section Leadership Plan must also be completed
as per standard PHS 398 instructions). If the multiple PDs/PIs option is not
chosen, applicants must identify a substitute PD/PI candidate to assure
continuity and a smooth transition of leadership when necessary.

In addition, either the PD/PI (or one of the multiple
PDs/PIs) or another senior researcher must be designated to have leadership
responsibility for the cancer care delivery research program. The
qualifications and experience of these individuals must be described,
documenting their respective abilities to organize and manage a community
oncology program that includes cancer prevention, control, screening/post-treatment
surveillance, treatment and imaging clinical trials and cancer care delivery
research as well as experience in accruing patients/participants to clinical
trials and/or conducting cancer care delivery research. The application should
also describe the strategy used by the PD(s)/PI(s) and the Institutional
official to delegate leadership responsibility with respect to the clinical
trials and cancer care delivery research selected for activation by the NCORP
Community Site and how the responsibility is delegated among Key/Senior
individuals.

A mentoring plan or program for leadership
development within the NCORP Community Site is recommended. If such a plan
exists or is under development, it should be described in the application.

It is expected that the PD(s)/PI(s) of the NCORP
Community Site will already be established as leader(s) in some capacity in the
community served by the Site. Characterize briefly these leadership roles
played by PD(s)/PI(s) and other senior investigators (if applicable). Describe,
for example, their relationships with community leaders in government and other
organizations with goals related to cancer care including the quality of and
disparities in cancer care (e.g., advocacy groups, county/state agencies). The
impact of these activities on the success of the NCORP Community Site as well
as on the overall community should be described including the potential to
translate research findings into community oncology practices. In addition, the
application should describe the leadership positions held by the PD(s)/PI(s)
with affiliated Research Bases and contributions made in that position along
with their impact. Parallel descriptions should be given for other Key/Senior
personnel, if applicable. Finally, leadership roles of the PD(s)/PI(s) and
other Key/Senior Personnel in national research organizations and professional
societies should be described.

Other
Professional Personnel. The application should propose a committed
multi-disciplinary oncology research team of professionals appropriate for its
expected clinical trial participation. With regard to cancer care delivery
research, the component(s) proposed for participation should have a committed
team involving oncologists, primary care and other providers, other
professionals (e.g., administrators, care coordinators, genetic counselors),
staff responsible for managing databases (e.g., cancer registries, electronic
medical records, claims databases) and a senior administrator to facilitate
implementation of studies that address organization and processes of care. A
description of both teams, how they plan to operate and interact, and how they
plan to lend their expertise to achieve the goals of the application should be
provided.

Sub-Section
C. Clinical Trial Research Program

Experience. Describe
the applicant’s experience relative to implementing cancer clinical trials in
the applicant’s practice setting(s) and provide a detailed summary of the
applicant’s accrual to NCI-approved cancer prevention, control, screening/post-treatment
surveillance, treatment, and imaging clinical trials as well as to any cancer
clinical trials sponsored by other non-profit organizations during the past 5
years. In addition, describe the applicant’s contributions (if any) during the
past 5 years to the research agenda of the Cooperative Groups and CCOP Research
Bases with which the applicant has been affiliated.

NOTE: Supplementary information on the applicant’s accrual record may be
summarized in a table as described in the Resources Section above.

Research
Priorities. Describe the plans and approaches for implementing and
conducting NCI-approved cancer clinical trials in the practice setting(s) of
the community served by the applicant team, including approaches for engaging
patients from minority and underserved populations, and hospitals, clinics and
other cancer care settings that serve these populations.

Describe in narrative form the types of cancer
prevention, control, screening/post-treatment surveillance, treatment, and
imaging clinical trials the applicant expects to activate during the award
period and include a description of the processes by which the applicant will
select an adequate number of clinical trials to meet or exceed accrual requirements
and/or planned accrual goals. The application should also describe why the
proposed clinical trial categories are appropriate for the
patients/participants in the NCORP Community Site's catchment area.

Include a list of the NCI cancer prevention, control,
screening/post-treatment surveillance, treatment, and imaging clinical trials
that are currently active as well as a list of the clinical trials that the
applicant plans on activating during the next year. Applicants who are not
current CCOP/MBCCOP award holders should provide a list of the currently active
clinical trials that they would expect to activate as an NCORP Community Site
if such clinical trials were still open to accrual once NCORP awards are made
as well as proposed implementation plans for activating such clinical trials
including specifics on patient/participant recruitment, compliance and
follow-up, etc.

Describe the readiness and capacity of the consortium
components to participate in clinical trials addressing the mechanisms of cancer
symptoms and treatment-related toxicities, molecularly-targeted agents to
understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis,
and management of precancerous lesions. The application should also describe
readiness and capacity to collect biospecimens and an approach to facilitating
understanding and adoption by community-based physicians of genomic medicine
and targeted cancer therapies as well as educating cancer patients and at-risk
individuals about these modalities.

The applicant’s recruitment and retention plans
should be described, including outreach efforts and methods for engaging the
community it serves, which may involve patient advocates. The plans for
recruiting women, racial/ethnic minorities, and underrepresented populations
(e.g., elderly, adolescents and young adults, patients who are under-and
uninsured, and patients who reside in rural or low resourced urban areas) must
be described. The information on women and minorities must be included under
Inclusion of Women and Minorities.

NOTE: Information on the applicant’s currently active NCI clinical trials
and/or NCI clinical trials expected to be activated may be summarized in tables
as described in the Resources Section above.

Research
Base Affiliations. The Research Base affiliations of the NCORP
Community Site should be described in the application. Applicants without
current CCOP or MB-CCOP awards should indicate their plan(s) for affiliations
based upon their review of existing Research Base portfolios. The rationale for
choosing these Research Base affiliations should be discussed. In addition, the
application should outline plans for contributing to the scientific agenda of
its affiliated Research Bases over the next project period. Examples of contributions
might include: participation/membership in Research Base scientific committees
or community liaison committees; serving as Chair(s) on cancer clinical trials;
authorship of joint publications, etc. The process for eliciting and
incorporating community input that informs the Research Base scientific agenda
should also be described.

NOTE: Information on the applicant’s current and/or planned Research Base
affiliations may be summarized in a table as described in the Resources Section
above.

Accrual
Plans. Each application must include plans for achieving accrual
goals to cancer prevention, control, screening/post-treatment surveillance,
treatment and imaging clinical trials over the next project period (5 years). Applications
must include evidence that the NCORP Community Site can meet or exceed the
required annual 80 new patient/participant accruals evenly distributed over the
available cancer prevention, control and screening/post-treatment surveillance clinical
trials versus treatment and imaging clinical trials, respectively.

Sub-Section
D. Cancer Care Delivery Research Program

Background
and Experience. Describe the capabilities to support the
implementation of the cancer care delivery research in the following areas:
genetic counseling, multidisciplinary care, care coordination/navigation
processes, supportive/palliative care and outreach programs for
minority/underserved populations. Describe the strategies (if any) used by
practitioners and senior management at the institution(s) to support the
implementation of cancer care delivery research. Outline the applicant's
potential contribution of the requested data to multi-site studies. Mention
other strategies considered including allowing staff to participate as subjects
of research. Describe the level of proficiency of medical staff in the
reporting of high quality medical data. List the participation in
institutional, national and/or regional initiatives focused on improving the
quality of care such as: American Society of Clinical Oncology Quality Oncology
Practice Initiative (QOPI®), Commission of Cancer Rapid Quality Reporting
System (RQRS), and Medicare's Physician Quality Reporting System (PQRS).

NOTE: Information
on the capabilities of the component(s) designated for participation in cancer
care delivery research in genetic counseling, multidisciplinary care, care
coordination/navigation processes, supportive/palliative care and outreach
programs for minority/underserved populations may be summarized in a table as
described in the Resources section above.

If applicable, describe the history and experience of
the designated component(s) in conducting cancer care delivery research during
the past 5 years (e.g., comparative effectiveness research, survey studies). The
description should include experience of relevant clinical professionals and
other staff working together as a team in implementing cancer care delivery
research as well as experience working with and merging multiple datasets
(e.g., registry, medical record, financial data) and providing data to outside
researchers and entities. Data provided in such studies could include existing
secondary data or prospective data collected from patients, practitioners
and/or other organizational personnel through surveys, focus groups or other
methods.

NOTE: Information on the past experience of the component(s) designated for
participation in cancer care delivery research may be summarized in a table as
described in the Resources Section above.

Research
Priorities. The application should identify specific study
categories in which the component(s) proposed for participation in cancer care
delivery research will participate as well as the processes used by the
component(s) for selecting, implementing, and conducting NCI-approved studies. This
cancer care delivery research may be observational or interventional in design.
Observational studies may address patterns of care or service utilization,
alternative organizational structures (e.g., integrated healthcare systems
versus free-standing hospitals), programs to improve health behaviors, etc. Interventional
studies may address implementation of new technologies (e.g., decision-making
tools to support genomically-informed therapies), new approaches for
multi-modality therapy planning and delivery, patient navigation and other care
processes, incorporation of new types of information (e.g., patient reported
information) into clinical decision-making, etc. These studies may also
incorporate disparities research questions.

If the designated component(s) have experience in
cancer care delivery research, describe the types of studies for which they
offer particular capabilities and strengths to the NCORP network. If the
designated component(s) are new to cancer care delivery research, describe
approaches the institution(s) will use for enhancing their understanding of and
preparedness for conducting cancer care delivery research. All applicants
should also describe the strategies that their designated component(s) will
take in the shaping of NCORP’s emerging cancer care delivery research agenda.

The application should include a description of the
approaches to be used by the designated component(s) for involving oncologists,
primary care physicians, other professionals (e.g., administrators, care coordinators,
genetic counselors), and staff responsible for managing databases (e.g., cancer
registries, electronic medical records, claims databases) in cancer care
delivery research. Applicants should also describe plans for the designated
component(s) to engage patients from minority/underserved populations, and
hospitals, clinics and other cancer care settings that serve these populations.

Provide plans explaining how the designated
component(s) will collect and manage data on program characteristics, patterns
of care and organizational policies and make these data available to the
affiliated Research Bases. These data would be expected to include but not be
limited to: descriptions of organizational structures, in-depth information on
specialists and specialized programs (e.g., palliative care), service
utilization data, billing/financial data, quality monitoring data, and
organizational policies such as personnel practices, clinical protocols and
reimbursement arrangements. Describe any perceived barriers in the types of
data that the designated component(s) would be able to report to investigators
for approved studies.

Sub-Section
E. Operations/Data Management Core

Institutional
Review Board (IRB). Outline the processes the consortium has in
place for ensuring compliance with regulations for IRB approval and informed
consent (compliance with 45 CFR 46) related to research involving human
subjects. A detailed description should be included under Protection of Human
Subjects of the application and cross-referenced to this sub-section of the
Research Strategy. Describe current (or planned) use of the NCI's Central
IRB for cancer treatment clinical trials from NCTN Network Groups and their
local IRBs for cancer prevention, control, and screening clinical trials and
cancer care delivery research. Describe the approach for ensuring that IRB(s)
with adequate expertise in cancer care delivery research is available.

Operations. Outline the standard operating procedures of the applicant’s team for
activating clinical trials as well as for recruiting, enrolling and monitoring
patients/participants. Describe the infrastructure the applicant has in place
to oversee day-to-day operations for conducting clinical trials. Also describe
the procedures to be implemented at the component(s) proposed for participation
in cancer care delivery research for activating studies and recruiting,
enrolling and monitoring participants. In addition, describe the plans for
communication among physicians and components and incentives for their
participation in studies.

Data
Management & Quality Assurance.Procedures for data
management and investigational drug monitoring must be described in the
application. For both clinical trials and cancer care delivery research, address
the following items:

Who is responsible for data management;

What is the source of records (e.g., hospital, office, clinic,
registry);

Who will collect and send patient materials (e.g., pathology
slides, port films, etc.) to the Research Bases;

What records (study flow sheets, reminder slips) will be included
on patient charts; and

How data will be transmitted (e.g., batch mode or in real time)
and whether mechanisms are in place for electronic data transfer.

In addition, for cancer care delivery research, address
the following:

How data will be obtained from existing repositories such as
cancer registries and claims databases; and

How standard data on organizational characteristics, patterns of
care and organizational policies will be assembled.

Describe how data management responsibilities are
distributed within and between components/sub-component(s) and the central
applicant office, if applicable. Describe how NCI and FDA requirements for
investigational drug management are handled. The internal quality assurance
plan of the applicant must be described in detail for both clinical trials and
cancer care delivery research. Assurance of quality is the joint responsibility
of the NCORP Community Site and its affiliated Research Bases. The applicant
should describe its policies and procedures for complying with federal
regulations related to confidentiality of patient data, including the Health
Insurance Portability and Accountability Act (HIPAA) regulations.

Audit
Performance.For applicants whose components
currently participate or have previously participated in CCOP Research Base clinical
trials, a brief description of the overall summary audit(s) results should be
provided.

NOTE: The summary audit report information may be summarized in a table
as described in the Resources Section above.

Protection
of Human Subjects: In addition to standard items, provide essential
details of the processes the consortium has in place for ensuring compliance
with regulations for IRB approval and informed consent (compliance with 45 CFR
46) related to research involving human subjects. Cross-reference this
description to Sub-section
E of the Research Strategy).

Targeted/Planned
Enrollment Table: Information on the targeted/planned
enrollment for minorities and members of both genders and children, if
applicable, should be based on accrual summarized across all diseases for the
planned project period, not on a study- or disease-specific basis.

Letters
of Support: In addition to standard items, include copies of
affiliation agreements with Research Bases or Research Base letters of intent
to support applicants.

Also include letters documenting institutional
commitments of the participating institutions. If applicable include letters of
intent to establish a consortium.

Letters of support for component sites participating
in Cancer Care Delivery Research should indicate the degree to which sites and
senior management are willing to provide service utilization, claims or service
encounters, cancer registry, practice (e.g., national quality reporting), and
financial data.

Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

The emphasis of this FOA is on the ability of the proposed Community Site to
recruit, enroll, and retain participants in multi-institutional cancer
prevention, control, and screening/post-treatment surveillance clinical trials,
quality-of-life studies embedded within treatment and imaging clinical trials
and studies on cancer care delivery. Proper affiliation and meaningful
contributions to the studies led by NCORP Research Base are also essential.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the NCORP Community Site to exert a
sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the NCORP Community Site proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a research infrastructure such as
NCORP Community Site that by its nature is not innovative may be essential to
advance a field.

Significance

Does the NCORP Community Site address an important
problem or a critical barrier to progress in the field? If the aims of the NCORP
Community Site are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the NCORP Community Site? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Specific to this FOA: Are
the qualifications, training, and experience of the PD(s)/PI(s) appropriate for
organizing and managing a community oncology research program that includes
accrual to NCI-approved cancer prevention, control, screening/post-treatment
surveillance, treatment and imaging clinical trials and cancer care delivery
research? How experienced are the PDs/PIs and other senior investigators in
terms of leadership roles in the community or nationally in the areas that may
enhance the NCORP Community Site and/or the research agenda of the affiliated
Research Bases? How effectively has the applicant assembled a multidisciplinary
oncology team for implementing a clinical trials agenda? Has (have) the
component(s) proposed for participation in cancer care delivery research
assembled a committed team for implementation of cancer care delivery research?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the NCORP Community
Site? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?

If the NCORP Community Site involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Organization and Structure

(Note: This entire criterion will receive one individual
score; the subcategories and aspects listed will be assessed but not scored
separately).

Organizational Structure. How appropriate is the planned organizational structure to accomplish the
proposed research activities?

Catchment Area. How
complete is the information provided on the catchment area (e.g., geography,
population, number of components)? Is the patient and provider pool large
enough to ensure that the program will be able to meet or exceed the accrual
requirements?

Clinical Practice Structure and
Partnerships. Is the clinical practice structure appropriate in
terms of the types and sizes of components (e.g., outpatient/inpatient
practices, hospitals/clinics/cancer centers) and the number of participating
oncologists, primary care and other providers? In particular, is this structure
adequate to support accrual goals and the conduct of cancer care delivery
research ?

Institutional Commitment and
Facilities. How convincing are the supporting documents for
institutional commitment from the components? Are the available facilities and
resources, including laboratories, in-patient and outpatient resources, cancer
registries, and space for administrative activities adequate to support the
proposed research activities?

Clinical Trials Research Program

(Note: This entire criterion will receive one
individual score; the subcategories and aspects listed will be assessed but not
scored separately).

Experience. How
successful has the applicant team been over the past 5 years in meeting or
exceeding the minimum annual accrual goals for their clinical trials? How
successful has the applicant been over the past 5 years in contributing to the
research agenda of affiliated Research Bases and Cooperative Groups, if
applicable?

Research Priorities.Are the applicant’s
priorities for implementing NCI-approved cancer clinical trials well thought
out and appropriate for the applicant’s organizational structure and capacity?

Does the applicant have a well-reasoned approach to
facilitating understanding and adoption by community-based physicians and
patients of genomic medicine and targeted cancer agents?

Are the recruitment, retention, and outreach plans
for clinical trials described likely to be effective?

Research Base Affiliations. Are the current or proposed affiliations consistent with the rationale provided
in the application? How likely is the applicant to contribute to the scientific
agenda of its affiliated Research Bases over the next project period, including
participation in scientific or community liaison committees; serving as
Chair(s) on cancer clinical trials; authorship of joint publications, etc.?

Accrual. Are the
proposed participant accrual plans matching the history of accrual by the
applicant team, the overall size of the applicant and its components and the
catchment area served? What is the likelihood that the applicants will be able
to achieve the required minimal or exceed the number of 80 accruals per year
over the proposed project period?

Cancer Care Delivery Research Program

(Note: This entire criterion will receive one
individual score).

Experience and Research Priorities. How strong are the applicants' capabilities in the proposed areas of focus for
cancer care delivery research? Are the study categories proposed by the applicant
appropriate for the experience and capabilities of the Site component(s)
designated for participation in cancer care delivery research?

Operations/Data Management Core

(Note: This entire criterion will receive one
individual score).

Are the processes for ensuring compliance with
regulations for IRB approval and informed consent (compliance with 45 CFR 46)
related to research involving human subjects adequate? Do the applicants use
(or plan to use) optimally the available relevant central and local resources? Are
the procedures for investigational drug management in compliance with NCI and
FDA requirements?

Are the procedures and workflow processes for
activating clinical trials and studies on cancer care delivery as well as for
recruiting, enrolling, and monitoring patients/participants clearly defined and
adequate? Are the plans for communication among physicians and components and
the incentives for participation in clinical trial and cancer care delivery
research well-reasoned?

Do the data management procedures appear to be adequately
robust for all the proposed activities? Is the internal quality assurance
plan/program clearly outlined and robust enough?

As applicable for the NCORP Community Site proposed,
reviewers will evaluate the following additional items while determining
scientific and technical merit, and in providing an overall impact score, but
will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed NCORP Community Site involves
clinical research, the committee will evaluate the proposed plans for inclusion
of minorities and members of both genders, as well as the inclusion of children.
For additional information on review of the Inclusion section, please refer to
the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the NCORP Community Site proposed,
reviewers will consider each of the following items, but will not give scores
for these items, and should not consider them in providing an overall impact
score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National
Cancer Institute, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response
to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center and will compete for available funds with all other
recommended applications submitted in response to this FOA. Following initial
peer review, recommended applications will receive a second level of review by
the National Cancer Advisory Board. The following will be considered in making
funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

The
PD(s)/PI(s) will have the primary responsibility for:

General responsibilities for the conduct of clinical
trials. The awardees’ programmatic responsibilities for the conduct of the
clinical and cancer care delivery research supported under the Cooperative
Agreements are described in the sections and documents listed below (including
subsequent modifications of these documents) which are incorporated by
reference as program-specific Terms and Conditions of Award:

NCI CTEP
Investigator’s Handbook (Manual for Participants in Clinical Trials of
Investigational Agents Sponsored by the Division of Cancer Treatment and
Diagnosis, NCI) available at http://ctep.cancer.gov/handbook/index.html.

Throughout these Terms and Conditions of Award,
“NCORP Community Site” refers to the organizational structure which is composed
of the key personnel (including the scientific and administrative leaders at
the Site) responsible for implementing NCORP studies and collaborating on
research goals of NCORP with NCORP Research Bases. In addition, throughout
these Terms and Conditions of Award, “NCORP Community Site,” refers to the main
community site as well as any component and sub-component site(s) included in
the award.

Awardees are allowed to accept funds from non-governmental
sources to support NCORP research that is not supported in part or in full by
the NCI. These funds are considered “Program Income” (e.g., additional per case
data management funding supplementing the NCI/DCP per case data management funding,
support for correlative science studies that use biospecimen or image
collections funded by the NCI/DCP for clinical trials under the NCORP Program)
and must be reported under the Terms and Conditions of Award for the NCORP
Program unless they are associated with an exempted category under the NIH
grant policy for program income, available at https://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#_Program_Income.

All key components of the NCORP Program must report
these funds to the NCI on an annual basis (in the non-competitive Type 5
application – the annual progress report) and must indicate the clinical trial
that the funds are being used to support (or other functional component if the
funds are not provided to support specific clinical trials). The Terms and
Conditions of Award for all the Cooperative Agreements under the NCORP Program
define the operational principles under which the awardees must function to
ensure the independence of the research conducted regardless of whether program
income is or is not available for any of the awards.

Definition of an NCORP
Community Site

An NCORP Community Site is defined as a consortium of
community hospitals and/or oncology practices or a community-based integrated
healthcare system that accrue participants to: 1) cancer prevention, control
and screening/post-treatment surveillance clinical trials designed and
conducted by NCORP Research Bases; 2) NCTN-sponsored cancer treatment and
imaging trials, as well as quality of life studies embedded within them; and 3)
cancer care delivery research studies (where “participants” can be defined as
patients, clinicians, and/or healthcare organizations). NCORP Community Sites
will also develop and enhance their data collection and study implementation
capabilities related to cancer care delivery research, provide organizational
data (e.g., financial, service utilization, processes of care, policies) in
support of cancer care delivery research studies, and provide site mentoring
(as appropriate) in cancer care delivery research.

Definition of Component: A hospital, cancer center,
physician practice, or other institution where patients/participants are
enrolled on a regular and ongoing basis to the menu of NCI-approved clinical
trials available to the NCORP Community Site as well as cancer care delivery
research studies if one or more of the NCORP components has been designated to
participate in cancer care delivery research. A letter of agreement between the
NCORP Community Site and each component(s) must be included in the grant
application. OHRP assurance requirements must be met.

Definition of Sub-Component: A sub-component is a
practice or organization that contributes to the overall accrual of a component
site but is located in a separate geographic location(s), is part of the
component’s business entity and is managed by the component.

Annual Accrual Threshold

The sites will need to demonstrate the ability to
meet or exceed the required annual 80 new patient/participant accruals evenly
distributed over cancer prevention, control and screening/post-treatment
surveillance trials and treatment and imaging trials, respectively. The sites
will also need to have at least one component site which will provide data
collection and study implementation capabilities related to cancer care
delivery research, organizational data (e.g., financial, service
utilization, processes of care) in support of cancer care delivery research
studies, and mentoring for other participating institutions in cancer care
delivery research.

The sites need to have at least one component
institution which will provide data collection and study implementation
capabilities related to cancer care delivery research, organizational data
(e.g., financial, service utilization, processes of care) in support of
cancer care delivery research studies, and mentoring for other participating
institutions in cancer care delivery research. These capabilities can be
provided by a single participating institution or different participating
institutions can provide these various capabilities.

Overall
Responsibilities for Community Sites

Scientific Leadership & Contribution to NCORP Activities

Investigators at NCORP Community Sites can
demonstrate scientific leadership for NCORP studies as well as support of and
participation in other NCORP activities in a variety of ways through their
membership in the Research Bases, including but not limited to the following:

Participating
in research design and protocol development for NCORP studies, including
collaborations between Research Bases and other NCI-supported programs and
investigators, particularly at their institution;

Co-authorship
on Research Base publications;

Participating
in the Scientific and Administrative Committees of the Research Bases;

Participating
in major meetings of the Research Bases and in other meetings deemed necessary
for performance of the activities of NCORP;

Participating
in NCORP activities and initiatives such as the NCI Scientific Steering
Committees and associated Task Forces and Working Groups and their activities
such as NCI Clinical Trials Planning Meetings or Cancer Care Delivery Planning
Meetings;

Participating
as members on the pediatric or adult NCI Central IRB

Providing
secondary data on patients, providers or organizations from sources such as
registries, electronic medical records, other clinical or administrative
databases in NCORP studies and providing sufficient data to meet the sample
requirements.

Providing
data on program characteristics, patterns and organizational policies of care
to the affiliated Research Base

Participate
in the activities of the cancer care delivery research Coordinating Committee
and adhere to the policies and procedures established by the Cancer Care Delivery
Research Coordinating Committee related to both scientific and administrative
activities of the committee, as applicable.

Participate
in any program evaluation processes that are conducted including interacting
with NCI representatives in coordinating the evaluation.

Young Investigator and
Leadership Mentoring/Training

Each NCORP Community Site should provide a mentorship
program or activities to involve young investigators at their institution in
cancer prevention, control and screening/post-treatment surveillance clinical
trials and cancer care delivery research studies and to help train them
eventually to take on senior leadership responsibilities for components of
research at the institution.

Governance & Organizational Structure: Each NCORP
Community Site is under the leadership of the Site PD(s)/PI(s), who
coordinate(s) all the scientific and administrative policies at the institution
related to NCORP activities as well as coordination with the Research Bases of
which the Community Site is a member. The Multiple Principal Investigator
(PD/PI) option is encouraged for these awards given the team science approach
of the research effort. Information on the Multiple PDs/PIs Option is available
at https://grants.nih.gov/grants/multi_pi/index.htm.
If this option is used, the Community Site should designate a “Contact PD/PI”
among the multiple PD/PIs. The Principal Investigator (or Contact Principal
Investigator under the Multiple PDs/PIs option) or designee is also responsible
for all grant-related activities related to this award and for communication
about these activities with the appropriate NCI/DCP staff.

The Community Site is responsible for development and
maintenance of a governance and organizational structure to coordinate NCORP
activities at the institution. The organizational structure of the Community
Site should be established with clear and appropriate staff roles and reporting
responsibilities, especially with respect to the role and reporting
responsibilities of any multiple PD/PIs.

It is anticipated that the Principal Investigator(s)
will be integrated into the scientific, clinical and cancer care delivery
research activities of each of the Research Bases to which the institution
belongs, thereby fostering collaboration between NCORP Network and other
investigators at the institution.

NCORP Community Sites will be expected to participate
in network-wide cancer care delivery research site data assessment initiatives
and integrate these findings to improve their ability to participate in cancer
care delivery research studies. Community sites will actively seek
participation in cancer care delivery research study concepts that are
appropriate to their organization and data collection capabilities.

Component & Sub-Component Network: If the
Community Site has component(s) and sub-component(s), the component network
must be clearly described (including reference to the distinct CTEP institution
code(s) for the component(s) and sub-component(s) that are used for patient
enrollment). The Community Site is responsible for complete monitoring and
management of the enrollment of patients at the component(s) and sub-component
site(s) to NCORP and NCTN clinical trials and cancer care delivery research
studies if they are included in the award. The component site(s) participating
in cancer care delivery research must be clearly identified. Any post-award changes
to components or sub-component sites will need to be approved by NCI per the
Organizational Change Guidelines (http://prevention.cancer.gov/ncorp).

Institution(s)/site(s) with the following NCTN Network
Group membership status may not be included as a component/sub-component site
of a NCORP Community Site unless the membership status is relinquished for
NCORP Community Site component status:

NCTN Lead
academic participating site (LAP) (academic center and its integrated
components)

Affiliates
or sub-affiliates included in a LAP cooperative agreement award

Network
Group Pediatric main member or affiliate sites

Other
Network Group main member, affiliate sites, or sub-affiliate sites.

All U.S. institutions/sites participating in NCORP
studies are required to use the NCI Central Institutional Review Board (CIRB)
for any NCORP study under the NCI CIRB’s purview. The NCI CIRB provides a
centralized approach to human subject protection through a process that
streamlines local IRB review of adult and pediatric national multi-center
cancer treatment trials. The Initiative consists of two central IRBs, one for
adult trials and one for pediatric trials. Adult NCORP trials do not currently
utilize the CIRB process. See http://www.ncicirb.org for
information on the requirements for a signatory institution under the NCI
CIRBs.

Study Operations – Conduct of Studies and Data
Management

The Community Sites should have a clearly articulated
process for prioritizing which NCORP trials to activate at their institutions.
Investigators at Community Sites form the cornerstone of the research programs
for NCORP and must perform at a high level through submission of accurate and
timely clinical data as well as ancillary materials necessary to support NCORP
(e.g., tumor specimens, imaging studies, pathology slides). The Principal
Investigator(s) at each Community Site is responsible for the performance of
their component sites for which it provides complete management services and
for assuring adherence to NCORP, NCI, OHRP, and FDA policies and procedures.

It is the responsibility of the Principal
Investigator(s) at the site to ensure that the procedures for data submission
for each NCORP protocol are understood by all investigators at the Community
Site and its components as well as at any sub-components, and that protocol-specified
data are submitted accurately and in a timely manner to the appropriate NCORP
Research Base.

The Community Site should have a process for
describing the capabilities of the component(s) designated for participation in
cancer care delivery research in the following areas: genetic counseling,
multidisciplinary care, care coordination/navigation processes,
supportive/palliative care and outreach programs for minority/underserved
populations. The Community Sites will identify strategies to be used by practitioners
and senior management at the institution(s) to support the implementation of
cancer care delivery research including providing requested data in support of
multi-site studies and participating and allowing staff to participate as
subjects of research.

Quality Assurance and Onsite
Auditing

Responsibilities for quality assurance of the data
(and biospecimens) submitted for NCORP studies as well as auditing include, but
are not limited to, the following:

Pathology:
Submission of appropriate materials to allow verification of pathologic
diagnosis, when relevant.

Diagnostic
Imaging: Submission of appropriate imaging data [images and associated
meta-data (clinical or technical) as appropriate] to allow central review of
staging, reported responses, and adequacy of imaging when required by a
particular protocol or for an audit.

Cancer
registry data

Electronic
or paper-based medical record data

Administrative
data (e.g., insurance status, demographic information)

Financial
data

Survey or
interview data

Onsite
Auditing: Cooperation with Research Bases’ data monitoring and onsite auditing
programs with appropriate compliance with the onsite auditing program
requirements. For cancer care delivery research, cooperation with Research
Bases’ data monitoring and onsite auditing programs with appropriate compliance
consistent with the Cancer Care Delivery Research Coordination Committee
auditing policy.

Site Clinical Trial Accrual

Community Sites are responsible for accrual to all
clinical trial studies conducted across NCORP and its components and
subcomponents, and for achieving threshold accruals. Investigators at the
Community Sites should be involved in the acquisition of protocol-specified
tumor specimens and other biospecimens in addition to all relevant protocol
required clinical data. Community Site investigators should ensure that
biospecimens and/or other data required for ancillary studies are submitted to
the appropriate laboratories/tumor banks and Research Base SDMCs.

Community Sites are responsible for assuring that institutional
investigators enrolling patients on NCORP studies are NCI registered
investigators (i.e., have Form FDA 1572 on file with the NCI). Community Sites
also must ensure that the main institution, as well as any components and
sub-components, are in compliance with NCI/DCTD/CTEP requirements for storage
and accounting for investigational agents, including complying with NCI/DHHS
Drug Accountability Records (DAR) procedures as described in the DCTD
Investigators' Handbook at: http://ctep.cancer.gov/handbook/index.html and are in compliance with FDA requirements for investigational agents.

Compliance with Federal
Regulations for Research

Community Site awardee(s) including the components
and sub-components should have policies and procedures for ensuring compliance
with federal regulations for the protection of human subjects. These include
the following:

Assuring
that all component and sub-component have current, approved Federal wide
Assurances (FWAs) on file with OHRP;

Assuring
that each protocol is reviewed by the site IRBs prior to participant entry (or,
where applicable, by the NCI CIRB) and that each protocol is reviewed annually
by the appropriate IRB as long as the protocol is active;

Assuring
that each participant (or legal representative) gives written informed consent
prior to entry on study;

Where
relevant, assuring that all regulatory documents verifying the FWA assurance
and initial and annual IRB approval of protocols as well as IRB approval of
required amendments are submitted to the Regulatory Support System (RSS) of the
NCI Cancer Trials Support Unit (CTSU) for NCORP trials;

Assuring
that all investigators comply with procedures for assuring timely reporting of
adverse events, including all expedited reporting of all serious adverse
events, per the protocol documents of NCORP studies in which the sites
participate.

IRB
Review of the Community Site

Institutional Review Board (IRB) review of the
Community Site grant is required. The IRB should determine and document that
the Community Site has sufficient mechanisms in place to ensure appropriate
data collection and data management of participants enrolled at the site (and
components and sub-components, if applicable) and secondary data collected from
the site as well as mechanisms to ensure protection of the confidentiality of
participant data, given the nature of the research involved. The IRB will
provide appropriate expertise for review of cancer care delivery research
studies. Information on this requirement for IRB review can be obtained on the
OHRP website at: http://www.hhs.gov/ohrp/.

NIH
staff have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:

An NCI Program staff members acting as a Project
Scientists/Coordinators will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below.
Additional NCI staff members may be designated to have substantial involvement
(e.g., in the role of Project Coordinators). The NCI Project
Scientists/Coordinators will not attend peer review meetings of renewal
(competing continuation) and/or supplemental applications. If such
participation is deemed essential, these individuals will seek NCI waiver
according to the NCI procedures for management of conflict of interest.

Additionally, an NCI program director acting as Program
Official will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice. Program
Official is expected to act as the director of the NCORP program. Another NCI
Program staff member will be named as Associate NCOPR Director, responsible for
cancer care delivery research components of NCORP. These individuals may also
have substantial programmatic involvement (as Project Scientists/Coordinators).
In that case, the individual involved will not attend peer review meetings of
renewal (competing continuation) and/or supplemental applications or will seek
NCI waiver as stated above.

The main NCI responsibilities are related to research
efforts of the NCORP Program and include but are not limited to the following
activities:

Coordination of NCORP efforts to match national priorities for
cancer prevention, control and screening/post-treatment surveillance research
and sponsoring NCORP strategy sessions;

Serving as resources available to NCORP awardees for specific
scientific information with respect to cancer prevention, control,
screening/post-treatment surveillance and cancer care delivery studies and
their design;

Serving as scientific liaisons to awardees of key components of
the NCORP Program;

Participation in scientific and organizational/executive meetings
of the NCORP components and NCORP committees;

Close involvement in the development of NCORP studies, including
review and approval of study protocols;

Participating in on-site audits of NCORP Community Sites and
Minority/Underserved Community Sites conducted by Research Bases;

Informing NCORP Program investigators of scientific opportunities
resulting from other relevant NCI-supported research programs;

Ensuring a high level of integration of complementary research
efforts on specific trials between NCORP and the NCTN;

Oversight of data and safety monitoring plans and boards for
NCORP clinical trials;

Oversight of data management and monitoring programs for NCORP
clinical trials as well as onsite auditing programs and quality assurance programs
for the NCORP Program, including oversight of core services for radiotherapy
and imaging supporting NCTN clinical trials;

Facilitating the coordination of research activities between the
NCORP Program and other NCI-sponsored programs and investigators;

Facilitating the evaluation of clinical trial concepts and
protocol development as well as review of correlative science study requests
for use of biospecimens collected in association with NCORP clinical trials;

Facilitating the evaluation of cancer care delivery research
concepts and protocol development;

Advising awardees concerning mechanisms established for quality
control of therapeutic and diagnostic modalities;

Monitoring the progress and performance of the NCORP Program;

Ensuring compliance with FDA requirements for investigational
agents and ensuring compliance with OHRP and other federal requirements and
regulations for research involving human research subjects; and

Responsibilities as a drug sponsor for investigational agent or
device development for NCI-sponsored or co-sponsored IND and/or IDE clinical
trials.

Details
on the NCI roles in the key NCORP activities are provided below.

Research Priorities

NCI/DCP staff members will be responsible for
maintaining a clear set of national priorities for cancer prevention, control
and screening/post-treatment surveillance research, based upon substantial
consultation with experts in the field. Additionally, NCI/DCCPS staff members
will maintain a clear set of national priorities for cancer care delivery
research, based upon substantial consultation with experts in the field. In
selected topic areas, particularly when spontaneous planning does not occur
within the Research Bases, DCP and DCCPS staff members (with support from the
Coordinating Center for Clinical Trials [CCCT]) will help in coordinating the
organization of Study Planning Meetings under the auspices of the NCI
Scientific Steering Committees. In addition, DCP and DCCPS staff may support ad
hoc scientific meetings to help achieve consensus on critical research
problems. These Study Planning meetings and ad hoc meetings will be composed of
investigators with established expertise in the particular field of interest
and will consist primarily of extramural scientists and members of the SSCs.
Priorities will be based upon the state of the science, NCORP Research Base
resources, and availability of funds. NCI staff will be responsible for prompt
dissemination of the recommendations from these meetings, particularly
regarding statements of research priorities from Study Planning meetings, and
the Research Bases will be encouraged to address these priorities.

Roles
of NCI Staff Members as Scientific Resource for NCORP Research

The NCI staff members will assist NCORP Research
Bases as appropriate, in developing information concerning the scientific basis
for specific trials or alternative study designs, operational and regulatory
issues, and will also be responsible for advising the Research Bases of the
nature and results of relevant trials and other studies being carried out
nationally or internationally. Where applicable, NCI staff members will also
provide updated information to the Research Bases on the efficacy, toxicity,
and availability of all Investigational New Drugs (IND) supplied by NCI to the
Research Bases. In addition, NCI will advise the Research Bases of potential
agents/interventions that will be relevant to new avenues of cancer prevention,
control and screening/post-treatment surveillance. NCI will also share with
NCORP updated information to compliment research initiatives and projects as
part of other NCI research cancer care delivery projects that may be relevant
to NCORP research priorities and concept development.

Concept Review

NCI program staff reviews each submitted concept to
determine that the proposed research is relevant to cancer prevention, control,
and/or care delivery and that the concept includes all required components. NCI
program staff will return to Research Bases concepts that do not fulfill these criteria
together with a letter that explains the reasons for not accepting the concept
for review.

The
DCP CRC or DCCPS CRC evaluates all NCORP concepts for the scientific rationale,
programmatic relevance; potential impact on cancer prevention, control and care
delivery; priority; design; statistical requirements; plans for conducting the
proposed study; the feasibility and appropriateness of the research for use by
NCORP Community Sites or in a community setting; the existence and nature of
concurrent clinical trials/studies in the area of research, including research
in other NCI-funded programs that may compete with or complement the proposed
study; and, where applicable, the availability of investigational agents.

Protocol Review

DCP/COPTRG will assist the Research Bases in clinical
trial design to develop a mutually acceptable protocol compatible with the
research interests, capabilities, and needs of the Research Base, its
affiliates, and NCI. The protocol review will focus on the inclusion in the protocol
of all information and procedures necessary for conducting a successful study.
Specific attention is paid to responses to concerns of the SSC and/or DCP/DCCPS
conveyed to the Research Base at the time of concept approval. Since the
rationale for the study and the broad study design have already received, these
are not generally the focus of a protocol review. However, if the protocol
differs from the concept in significant ways (e.g. change in endpoint, change
in participant eligibility criteria), the Protocol Review Committee will review
all aspects of the protocol to determine that the study has scientific validity
and is feasible to conduct in NCORP network.

Review of Clinical Trials and Other Studies in NCORP
Network for Crediting

All clinical trials and other study designs
originating at NCORP Research Bases must be reviewed and approved by the
Protocol Review Committee of the Division of Cancer Prevention (DCP) or
Division of Cancer Treatment and Diagnosis (DCTD), as appropriate, in order for
an NCORP Community Site to receive credit for participant accruals to such
studies.

Program Review and Federally Mandated Requirements

NCI/DCP may adjust funding annually based on the
planned scope and availability of funding. The NCI may also adjust funding,
withhold support, suspend or terminate the award, if NCORP Community Site
awardee fails to meet the performance requirements set forth in the Terms and
Conditions of Award in the FOA, and/or the level of performance changes
dramatically.

The final decision regarding funding for the all
NCORP awards, administrative supplements, and amounts selected for all “per
case management” funding, including “special per case management” funding and”
biospecimen per case management” funding for specific trials, rests with the
NCI/DCP and/or DCCPS. NCI/DCP also sets the threshold levels for accrual for
“high-performance” sites for NCORP (i.e., Community and Minority/Underserved
Community Sites, depending on the availability of funding).

The NCORP Director will designate Program Directors
to serve as cancer prevention and control liaisons on Data and Safety
Monitoring Boards (DSMBs), also known as Data Monitoring Committees (DMCs), for
NCORP phase 3 trials as well as phase 2/3 and any other phase 2 trials
monitored by the DSMB/DMC. One or more DCP/COPTRG staff will serve as
non-voting members at each Research Base DSMB/DMC meeting. NCI/DCP Program
Directors will review Research Base mechanisms for interim monitoring of
results, will monitor clinical trial progress, and will assess Research Base
compliance with NCI-established policies on Data and Safety Monitoring Plans
for Phase I and II trials and Data and Safety Monitoring Committees for Phase
III trials.

Because NCI/DCP staff serve as non-voting members of
the Research Base DSMBs/DMCs, to ensure compliance with NIH/NCI policies and
protocol requirements, NCI/DCP staff members recuse themselves from NCI/DCP
review of substantive protocol amendments (e.g., amendments for increases in
sample size or significant changes in trial design) for any study that is also
under review by a DSMB/DMC of which they are members, if confidential outcome
data on that study have been previously presented to the DSMB/DMC. When this
situation arises, the amendment is reviewed by NCI/DCP staff members who are
not members of that DSMB/DMC.

Additional NCI Scientific Support to NCORP Awardees

Each NCORP Research Base, Community Site, and
Minority/Underserved Community Site will also have a program staff member(s)
from DCP/COPTRG assigned to them who will act as liaisons for scientific
matters related to clinical trials and clinical research studies.

The NCI will also assign to each NCORP awardee a
program staff member(s) from DCCPS who will have clinical, health services and
behavioral research expertise to act as liaisons for scientific matters related
to cancer care delivery research studies.

The NCI will have access to all data (including
imaging data) collected and/or generated under this Cooperative Agreement and
may periodically review the data. The NCI may also review all records related
to awardees’ performance under the award for appropriate collection, review,
and distribution of biospecimens collected in association with NCORP clinical
trials.

The NCI reserves the right to reduce award budget,
withhold support, suspend, or terminate the award in cases of insufficient
patient accrual per the protocol specified timelines and/or NCI/DCP slowly
accruing guidelines for clinical trials, inability to meet the scientific aims
of the Cooperative Agreement, or noncompliance with the Terms and Conditions of
Award.

Areas
of Joint Responsibility include:

NCI Program staff members and the NCORP awardees will
collaborate on general aspects of study development and conduct. Areas for such
collaborations are particularly expected to include various administrative and
regulatory aspects such as:

Joint participation in the Collective Management of NCORP and
NCORP Cancer Care Delivery Research Coordination Committee;

Collaborations on clinical trial design (e.g., to ensure optimal
handling of clinical data for investigational drugs in the context of
intellectual property for potential licensing);

Co-development of collaborative clinical trials and international
clinical trials; and

Other aspects of compliance with federal and other applicable
regulations for clinical trial research and other studies conducted by Research
Bases.

Collective Management of NCORP

In order to provide for collaboration and
coordination of policies and procedures for NCORP, collective management is
needed. To achieve this goal, a core collective management team (i.e., NCORP
Leadership Management Committee) composed of 1 senior leadership representative
from each of NCORP Research Bases and key NCI program leadership from relevant
Divisions and Centers to discuss major policy issues and address concerns about
NCORP. The Committee will make recommendations to senior NCI leadership on the
Program. It is anticipated that the Committee will meet on at least a quarterly
basis by teleconference and/or in-person. Additional representatives from NCORP
may be invited to participate in meetings depending on the issues to be
discussed. It is also anticipated that there may be meetings held specific to
NCORP Directors of Operations/Group Administrators on a periodic basis to
discuss significant issues, as appropriate.

Specific areas that will require recommendations from
NCORP Leadership Management Committee include but are not limited to the
following:

Address
recommendations from the NCI Clinical Trials and Translational Research
Advisory Committee (CTAC) on strategic directions for NCORP Program

Establishment
and conduct of Toxicity-specific Working Groups

Establishment
and coordination of a standardized approach for health-related quality of life
and patient-reported outcome endpoints as secondary on treatment trials and
primary endpoints on cancer control trials

NCORP Cancer Care Delivery Research Coordination
Committee. NCORP will have a designated Committee to coordinate efforts
in cancer care delivery research. The Committee will be convened jointly by the
NCI and NCORP Research Base awardees. Initially, the committee will consist of
the following members:

Two leadership representatives from each Research Base (PDs/PIs
or other senior investigators), of whom at least one has expertise in cancer
care delivery research; and

Representatives from the NCI.

These initial members of the Committee will decide on its
final composition, structure, procedures, etc. Community Sites and
Minority/Underserved Community Sites will represented on an ad hoc basis.
Additional representatives of Research Bases and NCI as well as external
experts may also be involved in the activities of the Committee, e.g. as ad hoc
members.

The Committee will have access to NCORP-wide repository
information from NCORP Community Sites and Minority/Underserved Community Sites
(e.g., cancer registry data, processes of care data and data on organizational
characteristics and policies).

The specific functions of the Committee are expected to
include:

Developing an agenda and research priorities for NCORP cancer
care delivery research;

Tools and
procedures for linking EMR with financial and service utilization data; common
NCORP repositories of data from NCORP community sites (e.g., cancer registry
data, processes of care data, and data on organizational characteristics and
policies);

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Network Group representatives on the NCORP Leadership
Management Committee chosen by them without NIH staff voting, one NIH designee,
and a third designee with expertise in the relevant area who is chosen by the
other two. In the case of individual disagreement, the first member may be
chosen by the individual awardee. The appeals process and this special dispute
resolution procedure do not alter the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with PHS regulation 42 CFR
Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.